SPECIAL REQUIREMENTS OF THE 2014/33/EU DIRECTIVE ANNEX IV Part A EU-Type Examination for Safety Components for Lifts

Transcription

1 Title Reference Revision and date of entry into force Approved by SPECIAL REQUIREMENTS OF THE 2014/33/EU DIRECTIVE ANNEX IV Part A EU-Type Examination for Safety Components for Lifts PR.PART. ON/LIFT-IVa-e Rev. 2 of IMQ S.p.A. Business Unit Machinery, In-Service Inspections & Certification of Persons IMQ S.p.A Sole proprietorship Via Quintiliano, Milan, Italy

2 Index ART. 1. INTRODUCTION... 3 ART. 2. CONTENTS OF THE REGULATIONS... 3 ART. 4 CONFORMITY ASSESSMENT PROCEDURE... 3 GENERAL NOTE: this document is a translation to English language based on the original document PR. PART. ON/LIFT/IVa (in Italian language). In case of discrepancy, the original document prevails Page 2 of 6

3 Art. 1. INTRODUCTION As established in point 2.2 of the General Rules for assessing conformity to Community Directives for which IMQ operates as Notified Body No. 0051, these Special Requirements contain further details on the release by IMQ S.p.A. of relevant documentation certifying conformity to the specific applicable Directive. The following text reports the replacements, additions and amendments to the individual articles of the General Rules, repeating their numbering. The articles of the General Rules that are not reproduced in these Special Requirements are to be considered fully applicable. Art. 2. CONTENTS OF THE REGULATIONS 2. 3 EC/EU Certification Replacement The customer outsources EU-Type Examination of the safety components for lifts to IMQ as a notified body pursuant to the 2014/33/EU Directive (hereinafter, the Directive) as provided for in Annex IV, Part A. That annex requires IMQ to examine the technical project of a safety component for lifts. It also requires IMQ to verify and certify that the technical project of the safety component for lifts complies with the applicable essential health and safety requirements of Annex I of the directive, and that it will allow the lift in which it is correctly installed to comply with such requirements. Art. 4 CONFORMITY ASSESSMENT PROCEDURE 4.1 Presentation of the Request If accepted, the quotation must be sent by - after being signed and stamped - to the address of the IMQ contact person indicated in the quotation or the address verifiche.impianti@imq.it. All of the technical documentation required for the certification request, and any other additions, shall be sent on digital media (e.g. DC-ROM) to the following address: IMQ S.p.A. Via Quintiliano, Milan FAO: Business Unit Machinery, In-Service Inspections & Certification of Persons Operating Sector Lift and Machinery Estimate ref. No. (given at the top right of the quotation) Subject: Technical documentation Required documentation Replacement The technical documentation shall make it possible to assess whether the safety component for lifts meets the conditions referred to in point 2.3 above and shall include an adequate analysis and assessment of the risks. Page 3 of 6

4 The technical documentation shall specify the applicable requirements and cover, as far as relevant for the assessment, the design, manufacture and operation of the safety component for lifts. The technical documentation shall contain, where applicable, the following: a) a description of the safety component for lifts, including its area of use (in particular possible limits on speed, load and power) and conditions (in particular explosive environments and exposure to the elements); b) design and manufacturing drawings or diagrams; c) explanations necessary for the understanding of those drawings and diagrams and the operation of the safety component for lifts; d) a list of the harmonised standards applied in full or in part and, where those harmonised standards have not been applied, descriptions of the solutions adopted to meet the essential safety requirements of point 2.3 above, including a list of other relevant technical specifications applied. In the event of partly applied harmonised standards, the technical documentation shall specify the parts which have been applied; e) results of design calculations performed by or for the manufacturer; f) test reports; g) a copy of the instructions for the safety components for lifts; h) steps taken at the manufacturing stage to ensure that series-produced safety components for lifts conform to the safety component for lifts examined. Normally, these documents must be drawn up in Italian. Any other languages are only acceptable if stated in the quotation Verification of the technical file In accordance with Annex IV, Part A of the Directive, IMQ will examine the technical documentation and supporting evidence to assess the adequacy of the technical design of the safety component for lifts. If examination of the documentation reveals any Non-Conformities with respect to the essential requirements of the Directive, or part of the documentation is missing or incomplete, IMQ will inform the manufacturer in writing and will wait for the manufacturer to complete the documentation and/or change the design. Document Non-Conformities are classified as follows: - M = Major Non-Conformity: Evidence of a Non-Conformity with respect to the essential requirements of the Directive and/or lack of any of the documents required in the technical file. The manufacturer must complete the documentation to allow verification of the safety component in the field and/or in IMQ. - m = Minor Non-Conformity: The required documentation is there, but is obviously incomplete or inconsistent and does not allow full assessment of the safety component. Minor Non-Conformities can be solved after the assessment and do not prejudice verification of the safety component in the field and/or in IMQ. IMQ will notify the manufacturer in writing of any Non-Conformities found and, if there are major Non- Conformities, will wait for them to be solved (in terms of corrections and/or corrective actions) before verifying the safety component in the field and/or in IMQ. The manufacturer has 3 (three) months to send the missing or additional documentation. Otherwise, IMQ is allowed to decide to block the assessment procedure and request payment for the activities carried out up to that point. Page 4 of 6

5 4.2.3 Product verification After successfully completing the examination of the documentation, IMQ will: a) agree with the applicant on a location where the examinations and tests will be carried out; b) verify that the representative specimen has been manufactured in conformity with the technical documentation, and identify the elements which have been designed in accordance with the applicable provisions of the relevant harmonised standards, as well as the elements which have been designed in accordance with other relevant technical specifications; c) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the specifications of the relevant harmonised standards, these have been applied correctly; d) carry out appropriate examinations and tests, or have them carried out, to check - where the specifications of the relevant harmonised standards have not been applied - whether the solutions adopted by the manufacturer applying other relevant technical specifications enable the safety component for lifts to meet the conditions referred to in Annex I of the Directive and allow the lift on which it is correctly installed to comply with such requirements. If the testing and verification reveal any Non-Conformities with respect to the essential requirements of the Directive, IMQ will notify the manufacturer, which has 3 (three) months to implement suitable corrective actions. Any evidence provided shall be assessed in document form, by repeating the testing or by carrying out a specific assessment, depending on the changes. IMQ will notify the costs of carrying out this activity with a suitable quotation. IMQ shall draw up an evaluation report that records the examinations, verifications and tests carried out and their outcome. Without prejudice to its obligations vis-à-vis the notifying authorities, IMQ shall release the content of that report, in full or in part, only with the agreement of the manufacturer Assessment result The certificate is drawn up according to a standard model complying with Annex IV - Part A of the Directive and may include one or more annexes. The certificate is drawn up in two languages (Italian and English). It can be translated into other languages, as long as it has been previously stated in the quotation. The manufacturer shall keep with the technical documentation a copy of EU-type examination certificates, its annexes and additions at the disposal of the national authorities for 10 years after the safety component for lifts has been placed on the market. IMQ shall keep itself apprised of any changes in the generally acknowledged state of the art which indicate that the approved type may no longer meet the conditions referred to in Annex I of the Directive. IMQ shall determine whether such changes require further investigation and if so, it shall inform the manufacturer accordingly. The costs for the aforementioned activities are borne by the customer, following acceptance of the quotation provided by IMQ. The manufacturer shall inform IMQ of any modification to the approved type that may affect the conformity of the safety component for lifts with the conditions referred to in Annex I of the Directive or the conditions of validity of the EU-type examination certificate. IMQ will examine the modification and will inform the applicant whether the EU-type examination certificate remains valid or further examinations, verifications or tests are needed. IMQ will issue an addition to the original EU-type examination certificate or will ask for a new Page 5 of 6

6 application for an EU-type examination to be submitted, as appropriate. The costs for the aforementioned activities are borne by the customer, following acceptance of the IMQ quotation. The manufacturer shall keep at the national authorities disposal a copy of EU-type examination certificate,its annexes and additions - along with the Technical Documentation - for 10 years after the safety component for lifts has been placed on the market. Page 6 of 6